Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
An OECD 422 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening study has been conducted on the substance. No evidence of developmental effects such as deformations was observed; however, effects on reproductive performance were noted. These effects were the reduction in the number of uterine implantations at 330 and 750 mg/kg/day (and as consequence litter size) and were associated with reduced survival. The two females receiving 750 mg/kg/day that were not pregnant had an extended or irregular cycle however there was no link between cycles in the other females and litter size or post-implantation or pup mortality.
Due to the lack of developmental effects in the OECD 422 study, but observations of effects on reproductive performance, an OECD 443 study is considered the most appropriate study for further assessment reproductive effects. Although this study primarily assesses reproductive performance, it should also provide alerts for any developmental effect(s), in the event that such effects were no detected by OECD 422 study.
In conclusion, the conduct of a specific developmental toxicity study such as an OECD 414 study is not considered appropriate at this time from the scientific and also the animal welfare perspective as such a study will use a significant number of animals. Depending upon the outcome of the OECD 443 study, consideration may have to be given to further testing for reproductive effects and if required the need for a developmental study will be revisited at this time.
Data source
Materials and methods
Test animals
- Species:
- rat
Results and discussion
Applicant's summary and conclusion
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